- Posts by Andrew (Andy) P. Rusczek
Member of the FirmAttorney Andy Rusczek provides regulatory and compliance advice to a broad range of clients in the health care and life sciences industries, including hospitals, academic medical centers, and related providers as well as ...
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...
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Recent Updates
- Consumer Privacy Update: What Organizations Need to Know About Impending State Privacy Laws Going into Effect in 2024 and 2025
- Podcast: Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers – Diagnosing Health Care
- Global Hospital Budgets: A New Trend?
- Importance of Negotiating Tenant Improvement Allowance Provisions in Health Care Leases
- Podcast: Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care